Diversity and Inclusion of Patient-Centric Clinical Evidence: Opportunities for Clinical Pharmacologists

Session Description

Clinical trials to evaluate cancer treatments are rapidly evolving, leading to more complex clinical trials (e.g., appropriate comparators, changes in standard of care) and more eligibility criteria. Eligibility criteria provide a framework for defining the trial participant population and ensuring the safety of trial participants. However, overly restrictive eligibility criteria can significantly reduce the number of patients who may be eligible to participate in a trial, resulting in a homogeneous participant pool that limits data generalizability and understanding of the benefit–risk profile of the investigational therapy in broader populations.

This session addresses the topic of high emerging interest in the field of clinical trials and the broadening scope of clinical pharmacology. Efforts to broaden eligibility criteria in clinical trials are on the rise, recognizing that the rationale for exclusion criteria may not be scientifically justified.

Learning Objectives

1. Upon completion participants will be able to appreciate limitation of clinical trial eligibility criteria and various precision medicine approaches and impact of modernizing eligibility criteria compared with traditional inclusion/exclusion criteria.

2. Participants will also be able to learn about FDA's Project Equity and how the FDA is reexamining trial design and accrual strategies, streamlining eligibility criteria, and leveraging real-world evidence to generate evidence for improving diversity.

Session Schedule

11:00 AM - 11:05 AM ET
Introduction
Sreeneeranj Kasichayanula, PhD

11:05 AM - 11:10 AM ET
Eligibility Criteria and the Impact on Access to Clinical Trials
Donald Harvey, PharmD

11:10 AM - 11:15 AM ET
Diversity and Inclusion in Global Drug Development: An Opportunity for Model-Informed Precision Medicine.
Melaina Boyce

11:15 AM - 11:25 AM ET
Increasing Diversity: Opportunities for Clinical Pharmacologists During Drug Development and Approval
Michael A. Pacanowski, MPH, PharmD

11:25 AM - 11:45 AM ET
Fireside Chat

11:45 AM - 12:00 PM ET
Q&A and Closing Remarks